Coronary Artery DiseasePhase 4CASCADESNCT07254572
Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
A Phase 4 study testing Semaglutide 14 MG [Rybelsus], Dapagliflozin (Forxiga) and Metformin in people with Coronary Artery Disease and PreDiabetes, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, PreDiabetes
- What is being tested?
- Semaglutide 14 MG [Rybelsus], Dapagliflozin (Forxiga) and Metformin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jul 2025to 1 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80
- Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of >2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan)
- Coronary CT scan performed <3 months after inclusion in the study, at least of good quality
- Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization appointment or within 30 days prior to the screening/randomization appointment) or documented, positive result of an oral glucose load test (fasting blood glucose 100-125 mg% and 140-199 mg% 2h after a 75 g oral glucose load) performed up to 30 days before the screening/randomization appointment
- Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks
- Willing and able to give informed consent to participate in the study
- Willing and able, according to the researcher, to comply with all the requirements of the study
Who cannot join
- Severe valvular defect
- Clinical condition requiring surgical treatment of coronary artery disease
- Status after coronary artery bypass surgery
- Diagnosed diabetes or Hba1c>=6.5% at screening/randomization appointment
- Other severe medical conditions requiring scheduled hospital treatment at the time of the study
- Severe musculoskeletal conditions requiring specific rehabilitation recommendations
Show all 25Show fewer
- Diagnosed heart failure
- Presence of an artificial valve, cardiac pacing system or other implantable device (such as a cardioverter defibrillator)
- Severe arrhythmia/unexplained loss of consciousness
- Other contraindications to physical activity
- No consent to participate in the study
- Use of glucose-lowering drugs other than metformin
- Use of weight-loss drugs
- Condition after bariatric surgery
- Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment
- Uncompensated hyperthyroidism
- Pancreatic cancer
- Medullary thyroid cancer
- History of anaphylactic shock after iodine contrast administration
- Chronic kidney disease (eGFR <45 ml/min/1.73 m2)
- History of pancreatitis or active pancreatitis
- Body mass index (BMI) >40 kg/m2
- Pregnancy/lactation
- Participation in another clinical trial
- Other known contraindications to treatment with metformin, dapagliflozin or semaglutide
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
National Institute of Cardiology, Department of Coronary Artery and Structural Heart Diseases
Warsaw
Kinga Kotlińska, 223434600 ext. +48, kkotlinska@ikard.pl, cascades@ikard.pl
Agnieszka Nowicka, 223434380 ext. +48, anowicka@ikard.pl
About this study
Official title: A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months.
The diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT).
The study will evaluate the effect of treatment with flozin vs. semaglutide compared to treatment with metformin on the progression/regression of coronary atherosclerosis, change in plaque character, and control of cardiovascular risk factors.
- Conditions
- Coronary Artery Disease, PreDiabetes
- Being tested
- Semaglutide 14 MG [Rybelsus], Dapagliflozin (Forxiga), Metformin, Optimal Medical Therapy (OMT) And Lifestyle Intervention
- Keywords
- Coronary Artery Disease, Prediabetes, Coronary Plaque, Metformin, SGLT-2, GLP-1
- Medical subject headings
- Coronary Artery Disease, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 14 MG [Rybelsus]Drug
Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated
Dapagliflozin (Forxiga)Drug
Dapagliflozin 10 mg daily
MetforminDrug
Metformin 500 mg daily (up-titrated to 1000 mg daily if indicated)
Optimal Medical Therapy (OMT) And Lifestyle InterventionBehavioural
- cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines
- dietary counselling
- body weight management
- advice on optimizing physical activity levels
- advice on how to quit smoking if applicable
- psychological counselling
| Study group | Role | What they receive |
|---|---|---|
| DAPAGLIFLOZIN | Experimental | Dapagliflozin + OMT \& Lifestyle Intervention Receives: Drug: Dapagliflozin (Forxiga); Behavioral: Optimal Medical Therapy (OMT) And Lifestyle Intervention |
| SEMAGLUTIDE | Experimental | Semaglutide + OMT \& Lifestyle Intervention Receives: Drug: Semaglutide 14 MG [Rybelsus]; Behavioral: Optimal Medical Therapy (OMT) And Lifestyle Intervention |
| METFORMIN | Active comparator | Metformin + OMT \& Lifestyle Intervention Receives: Drug: Metformin; Behavioral: Optimal Medical Therapy (OMT) And Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS)
Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat) AND Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat)
Measured: 24 months
Secondary outcomes (30)
Evaluation of the effect of each of the tested drugs vs. control group on progression of coronary artery disease
% change in volume of noncalcified atherosclerotic plaque assessed by coronary CT (as treated) between baseline and end of study
Measured: 24 months
Comparison of the effect of semaglutide vs. flozin on coronary artery disease progression
% change in volume of noncalcified atherosclerotic plaque assessed by coronary CT (intention to treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of the effect of each study drug vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease
% change in volume of the entire atherosclerotic plaque assessed by coronary CT) (intention to treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease
% change in volume of individual components of atherosclerotic plaque assessed by coronary CT (intention to treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease (plaque conversion)
Conversion of non-calcified plaque to calcified plaque assessed by coronary CT (intention to treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk expressed as the dynamics of high-risk features
Change in the number of high-risk atherosclerotic lesions defined as the presence of at least 2 high risk features among:
- Spotty calcifications
- Low attenuation plaques (low attenuation plaque, i.e. plaque density <30 HU)
- positive remodeling
- napkin ring sign assessed by coronary TK (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk on pericoronary fat attenuation index
Change in the Pericoronary Fat Attenuation Index assessed by coronary TK (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body weight
Change in total body mass (expressed in kilograms) (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body mass index
Change in body mass index (BMI), calculated as following body mass index (BMI) = total body mass / (height)^2 and expressed in kg/m2 (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - total body fat
Change in totabl body fat mass (expressed in kilograms) measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body cell mass
Change in Body Cell Mass (BCM) (expressed in kilograms) measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - fat to mass ratio
Change in fat to mass ratio (FMR), calculated as following fat to mass ratoi (FMR) = total body fat (TBF) / skeletal muscle mass measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - visceral fat area
Change in visceral fat area (expressed in cm2) measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study
Measured: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - waist-to-hip index
Change in waist-to-hip index (WHI) measured by bioimpedance analysis between baseline and end of study
Measured: 24 months
Evaluation of change in inflammatory parameters in patients treated with semaglutide vs. patients treated with flozin
Change in concentration of high-sensitivity C-reactive protein between baseline and end of the study
Measured: 24 months
Evaluation of change in lipid levels in patients treated with semaglutide vs. patients treated with flozin
Change in
- total cholesterol
- low-density lipoproteins (LDL)
- high-density lipoproteins (HDL)
- non-HDL cholesterol
- triglycerides
- lipoprotein A concentrations between baseline and end of the study
Measured: 24 months
Evaluation of change in the percentage of glycated hemoglobin (HbA1c) in patients treated with semaglutide vs. patients treated with flozin
Change in the percentage of glycated hemoglobin (HbA1c) between baseline and end of study
Measured: 24 months
Evaluation of change in the percentage of patients with normal blood pressure in patients treated with semaglutide vs. patients treated with flozin
Change in percentage of patients with normal blood pressure defined as systolic pressure <140 mmHg and diastolic pressure <90 mmHg between baseline and end of study
Measured: 24 months
Evaluation of change in the percentage of patients smoking tobacco or electronic cigarettes in patients treated with semaglutide vs. patients treated with flozin
Change in the percentage of patients smoking tobacco (cigarettes, pipe, cigar, tobacco heating products) or electronic cigarettes as defined by the study protocol between baseline and end of study
Measured: 24 months
Evaluation of compliance with physical activity recommendations in patients treated with semaglutide vs. patients treated with flozin
Change in
- Percentage of patients classified in the "high" physical activity category;
- Percentage of patients classified in the "sufficient" physical activity category;
- Percentage of patients classified in the "insufficient" physical activity category between baseline and end of study
Measured: 24 months
Evaluation of dietary compliance in patients treated with semaglutide vs. patients treated with flozin
Change in the Dietary Approaches to Stop Hypertension (DASH) Index between baseline and end of study.
For each of the 8 DASH food groups, a score of 10 is assigned when the DASH recommendation is met, lower intakes are scored proportionately, and the 8 individual scores are summed to create the overall DASH adherence score, which could range from 0 to 80. The higher the score, the better the adherence.
Reference Günther AL, Liese AD, Bell RA, et al. Association between the dietary approaches to hypertension diet and hypertension in youth with diabetes mellitus. Hypertension. 2009 Jan;53(1):6-12
Measured: 24 months
Type 2 diabetes diagnosis
Number of patients diagnosed with of diabetes based on the criteria of the Polish Diabetes Association during the study
Measured: 24 months
Evaluation of the onset of heart failure requiring hospitalization
Number of patients hospitalized for heart failure during the study
Measured: 24 months
Number of unscheduled hospitalizations
Number of unscheduled hospitalizations during the study
Measured: 24 months
Number of major cardiovascular events and strokes (MACCE: death/myocardial infarction/revascularization/stroke) separately and combined
Number of cardiovascular events and strokes (MACCE: death/myocardial infarction/revascularization/stroke) during the study
Measured: 24 months
Homeostatic Model Change Assessment - Insulin Resistance (HOMA-IR)
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR) between baseline and of study
Measured: 12 and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - catalase
Change in plasma concentration of catalase between baseline and end of study
Measured: 12 months and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - superoxide dismutase (SOD)
Change in plasma concentration of superoxide dismutase (SOD) between baseline and end of study
Measured: 12 months and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - Oxygen Radical Absorbance Capacity (ORAC)
Change in concentration of Oxygen Radical Absorbance Capacity (ORAC) between baseline and end of study
Measured: 12 months and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - total antioxidant capacity (TAC)
Change in concentration of total antioxidant capacity (TAC) between baseline and end of study
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start10 Jul 2025
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Jan Henzel, MD, PhD, Principal investigator, National Institute of CardiologyMariusz Kruk, MD, PhD, Study chair, National Institute of CardiologyCezary Kępka, MD, PhD, Study chair, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254572
- Sponsor's protocol ID
- CSDS.IV/VIII/2023
- Acronym
- CASCADES
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-22/diabetes-total-risk-benefit-of-sglt2-inhibitors-and-glp1-agonists#.ZC8_KhOdj2E.link
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes
- ClinicalTrials.gov ID
- NCT07254572
- Acronym / sponsor ID
- CASCADES / CSDS.IV/VIII/2023
- Conditions
- Coronary Artery Disease, PreDiabetes
- Keywords
- Coronary Artery Disease, Prediabetes, Coronary Plaque, Metformin, SGLT-2, GLP-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called "flozin") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months.
The diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT).
The study will evaluate the effect of treatment with flozin vs. semaglutide compared to treatment with metformin on the progression/regression of coronary atherosclerosis, change in plaque character, and control of cardiovascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DAPAGLIFLOZIN | Experimental | Drug: Dapagliflozin (Forxiga), Behavioral: Optimal Medical Therapy (OMT) And Lifestyle InterventionDapagliflozin + OMT \& Lifestyle Intervention |
| SEMAGLUTIDE | Experimental | Drug: Semaglutide 14 MG [Rybelsus], Behavioral: Optimal Medical Therapy (OMT) And Lifestyle InterventionSemaglutide + OMT \& Lifestyle Intervention |
| METFORMIN | Active comparator | Drug: Metformin, Behavioral: Optimal Medical Therapy (OMT) And Lifestyle InterventionMetformin + OMT \& Lifestyle Intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 - 80
- Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of >2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan)
- Coronary CT scan performed <3 months after inclusion in the study, at least of good quality
- Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization appointment or within 30 days prior to the screening/randomization appointment) or documented, positive result of an oral glucose load test (fasting blood glucose 100-125 mg% and 140-199 mg% 2h after a 75 g oral glucose load) performed up to 30 days before the screening/randomization appointment
- Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks
Key exclusion criteria (25 listed)
- Severe valvular defect
- Clinical condition requiring surgical treatment of coronary artery disease
- Status after coronary artery bypass surgery
- Diagnosed diabetes or Hba1c>=6.5% at screening/randomization appointment
- Other severe medical conditions requiring scheduled hospital treatment at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 14 MG [Rybelsus]Semaglutide 3 mg daily - up-titrated to 7 mg daily if well tolerated - up-titrated to 14 mg daily if well tolerated | Drug | SEMAGLUTIDE |
| Dapagliflozin (Forxiga)Dapagliflozin 10 mg daily | Drug | DAPAGLIFLOZIN |
| MetforminMetformin 500 mg daily (up-titrated to 1000 mg daily if indicated) | Drug | METFORMIN |
| Optimal Medical Therapy (OMT) And Lifestyle Intervention* cardiological counselling aiming to reduce risk factors of atherosclerosis progression (LDL target, optimal medical therapy, comorbidities management, electrocardiogram) in accordance with current European Society of Cardiology guidelines * dietary counselling * body weight management * advice on optimizing physical activity levels * advice on how to quit smoking if applicable * psychological counselling | Behavioural | DAPAGLIFLOZIN, METFORMIN, SEMAGLUTIDE |
Primary outcome
Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS)
Time frame: 24 months
Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat) AND Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat)
30 secondary outcomes
Evaluation of the effect of each of the tested drugs vs. control group on progression of coronary artery disease
Time frame: 24 months
Comparison of the effect of semaglutide vs. flozin on coronary artery disease progression
Time frame: 24 months
Evaluation of the effect of each study drug vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease
Time frame: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease
Time frame: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease (plaque conversion)
Time frame: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk expressed as the dynamics of high-risk features
Time frame: 24 months
Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk on pericoronary fat attenuation index
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body weight
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body mass index
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - total body fat
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body cell mass
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - fat to mass ratio
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - visceral fat area
Time frame: 24 months
Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - waist-to-hip index
Time frame: 24 months
Evaluation of change in inflammatory parameters in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Evaluation of change in lipid levels in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Evaluation of change in the percentage of glycated hemoglobin (HbA1c) in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Evaluation of change in the percentage of patients with normal blood pressure in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Evaluation of change in the percentage of patients smoking tobacco or electronic cigarettes in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Evaluation of compliance with physical activity recommendations in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Evaluation of dietary compliance in patients treated with semaglutide vs. patients treated with flozin
Time frame: 24 months
Type 2 diabetes diagnosis
Time frame: 24 months
Evaluation of the onset of heart failure requiring hospitalization
Time frame: 24 months
Number of unscheduled hospitalizations
Time frame: 24 months
Number of major cardiovascular events and strokes (MACCE: death/myocardial infarction/revascularization/stroke) separately and combined
Time frame: 24 months
Homeostatic Model Change Assessment - Insulin Resistance (HOMA-IR)
Time frame: 12 and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - catalase
Time frame: 12 months and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - superoxide dismutase (SOD)
Time frame: 12 months and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - Oxygen Radical Absorbance Capacity (ORAC)
Time frame: 12 months and 24 months
Evaluation of change in the concentration of selected oxidative stress markers - total antioxidant capacity (TAC)
Time frame: 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publicationhttps://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-22/diabetes-total-risk-benefit-of-sglt2-inhibitors-and-glp1-agonists#.ZC8_KhOdj2E.link
- Study information in PolishLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Henzel, MD, PhD principal investigator
National Institute of Cardiology
Mariusz Kruk, MD, PhD study chair
National Institute of Cardiology
Cezary Kępka, MD, PhD study chair
National Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide 14 MG [Rybelsus], Dapagliflozin (Forxiga) and Metformin in people with Coronary Artery Disease and PreDiabetes, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Henzel, MD, PhD (+48 22 343 43 42, jhenzel@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07254572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.